A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause

Maneuver Marketing

Status

Completed

Conditions

Menopause

Treatments

Dietary Supplement: Provitalize Natural Menopause Probiotic

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06148714

20379

Details and patient eligibility

About

Symptoms of menopause can significantly affect overall quality of life. It is hypothesized that probiotic supplements can reduce the severity of these symptoms. This 90-day randomized controlled trial will examine the effects of the Provitalize Natural Menopause Probiotic on weight loss, waist circumference, sleep, and symptoms of menopause including hot flashes, night sweats, mood swings, anxiety, fatigue and brain fog. Participants will take either the test product or a placebo daily. All participants will complete study-specific questionnaires and provide sleep data from their Fitbit at Baseline, Day 30, Day 60 and Day 90. At Baseline, Day 30, Day 60 and and Day 90, participants will also provide a bodyweight measurement and a waist circumference measurement.

Enrollment

100 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women aged 45-65 years old
Must experience hot flashes and/or night sweats at least once per day
Must also be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes
Can be either natural or surgical menopause
Has not had a period in the last 12 consecutive months
Willing to adhere to the study protocol for the duration of the study
Willing to stop taking any other herbal remedies or supplements for the duration of the study
Self-reports as "generally healthy"
Has never taken Provitalize before
No planned invasive medical procedures for the duration of the study or in the three weeks leading up to the study start

Exclusion criteria

Not experiencing hot flashes and/or night sweats at least once per day and two other symptoms of menopause such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes
Unwilling to stop taking any other herbal remedies or supplements for the duration of the study
Current use of conventional hormone replacement therapies, or plan to start during the study duration
Current use of hormonal birth control, or plan to start during the study duration
Known allergies or hypersensitivities to any product ingredients
Current or history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear
Anyone with any known severe allergies requiring the use of an epi-pen
Unwilling to adhere to the study protocol
Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders
Pregnant, breastfeeding or trying to conceive
Currently taking a prescription sleep aid